Health product recall

Hemo-O-Lock & Endowrist Clip Applier

Last updated

Summary

Product
Hemo-O-Lock & Endowrist Clip Applier
Issue
Medical devices - Performance issue
What to do

If instruments cannot be manipulated in a precise and controlled manner, return it to manufacturer. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Large Hem-O-Lock Clip Applier

All lots.

420230

Endowrist Medium-Large Clip Applier

All lots.

420327

Small Clip Applier

All lots.

420003

Clip Applier

All lots.

470230, 470327, 470401

Issue

Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints on the issue, which indicated non intuitive motion during an attempt to close the grips of the instrument and place a clip.

Recall start date: July 1, 2022

Additional information

Details
Original published date: 2022-07-13
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Health product - Medical device - General hospital and personal use
Companies

Intuitive Surgical Inc.

1266 Kifer Road, Sunnyvale, California, United States, 94086

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64345